Quantia IgE— 510(k) K214068

Substantially Equivalent

Biokit, S.A.

FDA 510(k) clearance K214068 for Quantia IgE, Substantially Equivalent on 2023-02-21. Applicant: Biokit, S.A..

Clearance details

Applicant: Biokit, S.A.
Product code: Code DGC
Advisory panel: Immunology
Date received: 2021-12-27
Decision date: 2023-02-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Lliçà D´Amunt, ES

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